MAUDE Adverse Event Report: DATASCOPE CORP PERFUSION PACK; CARDIOPULMONARY DEVICE

Model Number BO-TOP 15500

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2012

Event Type  malfunction  

Event Description

The y-connectors on line #5 leaked slightly when they were coming off pump at the end of the case.Did not effect the case and the pack was disposed of.

Manufacturer Narrative

The hosp indicated that the tie wrap (line 5 connection e) could be rotated with very little pressure around the tubing it was securing.Since no product was retuned for eval, based on the complaint, photographs and feedback from the hosp, the tie wrap either was applied to the tube incorrectly or was not inspected properly.As for the leaks occurring at the in/out connections to the pre-bypass filter, no cause determination can be made since no other info or kits were supplied.The hosp has requested a design change to add tie wraps to these connection on future kits, which is currently in process.The hosp is not going to return any kits and will not require us to review stock.They have advised that they will add an add'l tie wrap, if required.The loose tie wrap issue was discussed with the manufacturing personnel and they were re-trained on the proper manufacturing and inspection methods for tie wrap connections.(b)(4).

• Brand Name: PERFUSION PACK
• Type of Device: CARDIOPULMONARY DEVICE
• Manufacturer (Section D): DATASCOPE CORP; fairfield NJ
• Manufacturer Contact: jason sousa ; 15 law dr.; fairfield, NJ 07004 ; 9737097256
• MDR Report Key: 4093125
• MDR Text Key: 19590177
• Report Number: 2248146-2014-00390
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/17/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2013
• Device Model Number: BO-TOP 15500
• Device Catalogue Number: 701051863
• Device Lot Number: 13870-08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2012
• Initial Date FDA Received: 08/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1